A thunderbolt of fear struck 20 million Americans with severe disabling pain this past Monday as a result of an Oklahoma court’s decision to hold Johnson & Johnson financially responsible for the opioid crisis in the state — not because most people care about Big Pharma, but because they do care about their own lives. These are people who live in the shadows, afraid of being further stigmatized, ostracized and treated as if they are responsible for the opioid crisis.
These are people who live in the shadows, afraid of being further stigmatized, ostracized and treated as if they are responsible for the opioid crisis.
The reverberation will be felt throughout every aspect of society: Policymakers will be more emboldened to restrict access to opioids. Doctors will follow suit, as will insurance companies. And politicians will point to the pharmaceutical industry as the villain while demonizing a class of drugs that remain the only affordable or available treatment for millions of people — even as the drugs most responsible for the crisis (illegally made fentanyl, heroin, cocaine and other illicit drugs) are largely ignored.
We have a window into what to expect following the decision — in other words, the effect of more restrictions on legal opioids — by looking at the consequences of the Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain.
Doctors have been working in fear since the March 2016 publication of the CDC guideline, after which an estimated 70 percent of physicians have dramatically reduced or stopped prescribing opioids. Many worried that they would lose their licenses if they continued to give patients opioids, while some physicians are being criminally prosecuted for prescribing outside the guidelines. Of course, unscrupulous doctors should be held accountable, but not just because they deviated from the CDC recommendations.
To provide the relief their patients need without running afoul of the CDC's guidelines, they must navigate their way through an arduous appeals process with payers, pharmacies and health care systems. Some providers now refuse to take on new pain patients or have terminated professional relationships with existing patients who have been prescribed an opioid for pain. It has simply become too costly and professionally risky to treat people with chronic pain.
This can have devastating effects on patients, very few of whom are addicts. The National Institute on Drug Abuse estimates the number is well under 10 percent, and as low as 1 percent, though it’s impossible to know precisely. But those who develop addictions are not always prescribed an opioid; those who are tend to move from medical prescriptions to the street.
People in pain who aren’t addicted find it more difficult to access compassionate care; some of them, too, will turn to the streets to find pain relief through the lethal, illicit opioids such as smuggled fentanyl that are flooding our communities. Others will be forced to suffer more as they become increasingly unable to work or engage in everyday activities. Some people who can no longer get prescription opioids may even choose suicide over the alternatives.
The insurance companies have contributed to these dire choices, with payers setting limits on the amount of opioids authorized, based on the CDC guideline's recommendations — frequently overriding physicians' decision making. Pharmacies play a part as well. Chains have limited the amounts to be dispensed, based on the guidelines, not on patients' needs. Furthermore, the Centers for Medicare and Medicaid Services has made pharmacists responsible for determining the appropriateness of physicians' prescriptions, and this has set up confrontational interactions between them.
Now, all parties involved in manufacturing, distribution, dispensing and prescribing are likely to place the brakes on their opioid-related activities to avoid being caught in a web of lawsuits and accusations of malevolence. I’m facing such lawsuits myself, though several have recently been dismissed
I expect all of these problems to increase in the wake of the Oklahoma verdict, delivered by Cleveland County District Court Judge Thad Balkman on Monday. Already, more than 30 states have passed laws based on the CDC guidelines. Attorneys general have adopted the CDC guidelines as a standard of care and the basis for prosecution in some cases. Civil suits have used the same reference to file malpractice claims. This case only encourages more of this action.
The verdict may also deter the pharmaceutical industry from investing in pain therapies or other conditions involving drugs that can be abused. Prescription opioids are only one such class of drugs: Stimulants, cannabinoids, gabapentinoids and benzodiazepines might also find themselves in the crosshairs of future plaintiffs. Recognizing they may be held at least partly accountable for a societal problem, pharmaceutical companies could avoid research and investment in many areas that desperately need new discoveries — such as opioid abuse deterrents, which companies have already backed away from.
To the extent that Johnson & Johnson and other members of Big Pharma have contributed to this crisis, they should be held accountable, even if there are some problematic unintended consequences. But so, too, should the institutions that have failed to provide access to affordable alternative therapies for pain and treatment for opioid addiction for the uninsured or underinsured, as well as those who criminalize the disease of addiction.
Many anti-opioid, anti-Pharma people will feel victorious because of the Oklahoma decision, but there are no winners here.
Indeed, there is plenty of room to cast blame in this complex situation, and we need solutions that don’t pit people with pain against people who develop addictions. We can solve the national drug crisis, but it won’t happen until there is greater understanding of the needs of both types of patients. That won't take place in court.
Many anti-opioid, anti-Pharma people will feel victorious because of the Oklahoma decision, but there are no winners here. Johnson & Johnson's loss won’t solve the drug crisis, and it certainly won’t help the 20 million Americans with high-impact pain.